The Limitation of Litigation for Fabrication

Researchers have deadlines to meet, grants to apply for, usually classes to teach, and data to collect. When data doesn’t go their way, do they have time to, once again, apply to the Internal Review Board and run a whole new experiment? In a study conducted by Dr. Daniele Fanelli, a pool weighted average of 1.97% of scientists admitted to fabricating, falsifying, or modifying data at least once in their life. Aside from fabrication, it was found that approximately 33.7% of scientists admit to engaging in other dubious research practices (Fanelli, 2009). According to the Office of Research Integrity, “Fabrication is making up data or results and recording or reporting them.” The intent to deceive is what makes fabrication so unethical.

In 2016, a large amount of media interest included reports of regulators from the United States, European Union, and the World Health Organization red-flagging the quality of Indian-made pharmaceutical drugs for over ten years. A top Indian contract research organization, GVK Bio had regulators finding evidence of fabrication of clinical test data. This resulted in the ban of 700 pharmaceutical drugs from foreign and Indian firms that were approved by tests conducted by GVK Bio (Thakur, 2016). In 2014, a molecular biologist, Sandra Dunn, at University of British Columbia in Vancouver, was investigated when suspicions of research misconduct were reported. The investigation resulted in four findings of fabrication, four failures to keep records, three self-plagiarism findings, one account of lack of scientific and rigor, and one failure to acknowledge contribution. In an interview with The Vancouver Sun, Dunn said that she left of her own accord and was not fired (Shore & Fuman, 2016). Similarly, in 2012, The Department of Health and Human Services found Mona Thiruchelvam, Ph.D., from the University of Medicine and Dentistry of New Jersey guilty in engaging in research misconduct. She falsified and fabricated cell count data that she reported in grant applications, a poster, and a manuscript in preparation. This resulted in her being excluded from contracting with any agency of the United States Government and retraction from two paper (Dahlberg, 2012).

Within university cases, sanctions were made. The case of the GVK Bio resulted in the banning of 700 drugs but no legal actions were taken, the Food and Drug Administration were keeping tabs but allowed them to continue sales. Should there be legal consequences for fabrication of research data? By common sense, if situations were very serious and became life-threatening, serious legal action would be taken. Dunn was researching and writing papers on new treatments for aggressive brain and breast cancers. Is this not serious enough?

Dahlberg, J. (2012, June 28). Findings of Research Misconduct. Federal Register Volume 77(125).

Fanelli, D. (2009). How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data. PLoS ONE, 4(5), e5738. http://doi.org/10.1371/journal.pone.0005738

Shore, R. & Fumano, D. (2016, December 16). Scientist criticized by UBC probe condemns investigation process. The Vancouver Sun (British Columbia).

Thakur, D. (2016, December 20). ‘Pharma industry’s playbook on low-quality drugs’. Indian Express.